Devices
AdvaMed and Abbott Laboratories say an FDA proposed rule on electronic submission of labeling for certain home-use medical devices is redundant and should not be pursued. The AdvaMed comment letter says the rule is not needed because device labeling information is widely available to users, and many manufacturers of
Drugs
CDER’s sixth annual Novel Drug Summary says the Center approved 22 novel drugs in calendar year 2016, either as new molecular entities (NMEs) under NDAs or as new therapeutic biologics under BLAs. “Novel drugs are often innovative products that serve previously unmet medical needs or otherwise significantly help to
Drugs
Symbiomix has submitted an NDA for Solosec (secnidazole oral granules) for treating bacterial vaginosis (BV). The company describes Solosec as a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. In clinical trials Solosec demonstrated efficacy for treating BV with only a single, oral, two-gram dose, it
Biologics
CBER says it is considering developing 14 guidances in three categories during calendar year 2017. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following
Drugs
FDA says it has approved a Roxane Laboratories ANDA for the first generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution for treating cataplexy and excessive daytime sleepiness in patients with narcolepsy. The approval requires Roxane to implement strict safety controls on prescribing and dispensing under a Risk Evaluation
FDA Policy/General
[Analysis by Jim Dickinson] While the Obama administration’s defense of FDA was, fundamentally, as feeble as its latter-day predecessors, the FDA-relevant signs from the incoming Trump Administration are that the very idea of FDA defense could be out the window. The agency’s bedrock premise – proof of
Drugs
FDA has accepted for review an Ezra Innovations NDA for investigational drug product EZR-104 for treating hypertension and heart failure. The agency has set a user fee review target date of 9/10. EZR-104 combines angiotensin receptor blocker valsartan with its Rubireten delivery technology. “This novel formulation is
Drugs
Mallinckrodt has agreed to pay $100 million to settle Federal Trade Commission charges that it violated antitrust laws when its subsidiary Questcor acquired the rights to a drug that threatened its monopoly in the U.S. market for adrenocorticotropic hormone (ACTH) drugs. Acthar is a specialty drug used as a
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Assessment of Abuse Potential of Drugs.” The document is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. Specifically, it provides recommendations for
FDA Policy/General
Federal Register Notice: FDA has determined that Endo Pharmaceuticals’ Parkinson’s drug Symmetrel (amantadine hydrochloride), syrup, 50 milligrams/5 milliliters (50 mg/5 mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency can allow ANDA approvals for products that reference Symmetrel
Drugs
Former Rep. Henry Waxman (D-CA) says that some of the financial incentives under the Orphan Drug Act and the Waxman-Hatch Act have resulted in financial windfalls for drug companies and may no longer be needed. Waxman offered his assessment in an online Kaiser Health News video interview. He
FDA Policy/General
In his final days as FDA commissioner, Robert Califf announced 1/18 that the agency is evaluating changes to the advisory committee (AC) process. He acknowledged that advisory committees have “been the subject of ongoing discussions concerning their impartiality, their transparency, and how they affect decisions made about FDA-regulated
Drugs
FDA has denied an 8/18/16 Lilly petition asking that it open notice and comment rulemaking to revise the regulatory definition of “biological product” such that Forteo (teriparatide [rDNA origin] injection) would fall within the statutory definition under the Biologics Price Competition and Innovation Act. Specifically, the petition asked
Drugs
As part of FDA’s reexamination of its rules and policies relating to regulated industry communication on unapproved uses of approved or cleared medical products, the agency has submitted a memorandum to the docket “to provide additional background and seek input on the full range of issues to consider as
Drugs
HHS, FDA and 13 other federal agencies have issued a final rule updating regulations that safeguard individuals who participate in research. The agencies say that most provisions in the rule take effect in 2018. “The new rule strengthens protections for people who volunteer to participate in research, while ensuring that
Drugs
A small study of hematologists/oncologists found that nearly 80% of them who tweeted about drugs or medicines had financial conflicts of interest ranging from $100 to upwards of $1,000. Modern Healthcare says the study, which appeared in JAMA Internal Medicine, reports that Twitter gives doctors direct access to
FDA Policy/General
Mintz Levin attorneys Joanna Hawana and Bethany Hills says changes are likely to FDA in 2017, both arising from the election of Donald Trump and from approval of the 21st Century Cures Act and “must-pass” user fee legislation. Writing in an online blog post, the two say that while
Drugs
A Government Accountability Office (GAO) study says that FDA has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection, but has not assessed the contributions its foreign offices make to drug safety. “FDA has made progress in its strategic planning for its offices in
Drugs
FDA has denied an AbbVie 12/17/15 petition asking the agency to ensure that applicants seeking interchangeability determinations meet the “Safety Standards for Determining Interchangeability” in the Public Health Service Act for each condition of use for which the reference product is licensed, regardless of whether the applicant intends
Drugs
FDA will publish 1/19 a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers, to provide the agency’s answers to common questions about the communication of healthcare economic information (HCEI) about approved prescription drugs by medical product manufacturers, packers, distributors,
FDA Policy/General
FDA’s Center for Veterinary Medicine (CVM) 1/18 announced an alert to pet owners, veterinarians, health care providers and pharmacists that “pets are at risk of illness and death when exposed to the topical cancer medication fluorouracil cream USP 5% intended for use in people.” It said the agency